Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 95358537 | 9535853 | 7 | F | 20130203 | 20160907 | 20130507 | 20160914 | PER | PHEH2013US003962 | NOVARTIS | 4.59 | YR | M | Y | 21.77000 | KG | 20160914 | CN | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 95358537 | 9535853 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 2.5 MG, QD | Y | 22334 | 2.5 | MG | QD | ||||||
| 95358537 | 9535853 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | Y | 22334 | 5 | MG | QD | ||||||
| 95358537 | 9535853 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 2.5 MG ONE DAY AND ALTERNATING 5 MG ON OTHER DAY | Y | 22334 | |||||||||
| 95358537 | 9535853 | 4 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 2.5 MG, QD | Y | 22334 | 2.5 | MG | QD | ||||||
| 95358537 | 9535853 | 5 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | Y | 22334 | 5 | MG | QD | ||||||
| 95358537 | 9535853 | 6 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | UNK | Y | 22334 | |||||||||
| 95358537 | 9535853 | 7 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG ALTERATING WITH THE 5 MG EVERY OTHER DAY | Y | 22334 | |||||||||
| 95358537 | 9535853 | 8 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG, QD | Y | 22334 | 7.5 | MG | QD | ||||||
| 95358537 | 9535853 | 9 | C | ONFI | CLOBAZAM | 1 | Unknown | UNK | Y | 0 | |||||||||
| 95358537 | 9535853 | 10 | C | VIGABATRIN | VIGABATRIN | 1 | Unknown | UNK | Y | 0 | |||||||||
| 95358537 | 9535853 | 11 | C | DILANTIN | PHENYTOIN | 1 | Unknown | UNK | Y | 0 | |||||||||
| 95358537 | 9535853 | 12 | C | MELATONIN | MELATONIN | 1 | Unknown | UNK | Y | 0 | |||||||||
| 95358537 | 9535853 | 13 | C | RISPERDAL | RISPERIDONE | 1 | Unknown | UNK | Y | 0 | LIQUID | ||||||||
| 95358537 | 9535853 | 14 | C | B6 | PYRIDOXINE HYDROCHLORIDE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 95358537 | 9535853 | 15 | C | L-LYSINE | LYSINE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 95358537 | 9535853 | 16 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | UNK | Y | 0 | |||||||||
| 95358537 | 9535853 | 17 | C | TRAZODON | TRAZODONE HYDROCHLORIDE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 95358537 | 9535853 | 18 | C | MULTI-VIT | VITAMINS | 1 | Unknown | UNK | Y | 0 | |||||||||
| 95358537 | 9535853 | 19 | C | FELBATOL | FELBAMATE | 1 | Unknown | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 95358537 | 9535853 | 1 | Ganglioglioma |
| 95358537 | 9535853 | 9 | Product used for unknown indication |
| 95358537 | 9535853 | 10 | Product used for unknown indication |
| 95358537 | 9535853 | 11 | Seizure |
| 95358537 | 9535853 | 12 | Product used for unknown indication |
| 95358537 | 9535853 | 13 | Product used for unknown indication |
| 95358537 | 9535853 | 14 | Product used for unknown indication |
| 95358537 | 9535853 | 15 | Product used for unknown indication |
| 95358537 | 9535853 | 16 | Product used for unknown indication |
| 95358537 | 9535853 | 17 | Product used for unknown indication |
| 95358537 | 9535853 | 18 | Product used for unknown indication |
| 95358537 | 9535853 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 95358537 | 9535853 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 95358537 | 9535853 | Abnormal behaviour | |
| 95358537 | 9535853 | Anger | |
| 95358537 | 9535853 | Body temperature increased | |
| 95358537 | 9535853 | Concomitant disease progression | |
| 95358537 | 9535853 | Cough | |
| 95358537 | 9535853 | Dental caries | |
| 95358537 | 9535853 | Epilepsy | |
| 95358537 | 9535853 | Inappropriate affect | |
| 95358537 | 9535853 | Mood altered | |
| 95358537 | 9535853 | Oral pain | |
| 95358537 | 9535853 | Sleep disorder | |
| 95358537 | 9535853 | Upper respiratory tract infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 95358537 | 9535853 | 1 | 20130203 | 0 | ||
| 95358537 | 9535853 | 2 | 20130308 | 0 | ||
| 95358537 | 9535853 | 4 | 20130426 | 0 | ||
| 95358537 | 9535853 | 5 | 20140114 | 20160704 | 0 | |
| 95358537 | 9535853 | 6 | 201411 | 0 | ||
| 95358537 | 9535853 | 7 | 201505 | 0 | ||
| 95358537 | 9535853 | 9 | 20160704 | 0 | ||
| 95358537 | 9535853 | 10 | 20160704 | 0 | ||
| 95358537 | 9535853 | 11 | 20160704 | 0 | ||
| 95358537 | 9535853 | 12 | 20160704 | 0 | ||
| 95358537 | 9535853 | 13 | 20160704 | 0 | ||
| 95358537 | 9535853 | 14 | 20160704 | 0 | ||
| 95358537 | 9535853 | 15 | 20160704 | 0 | ||
| 95358537 | 9535853 | 16 | 20160704 | 0 | ||
| 95358537 | 9535853 | 17 | 20160704 | 0 | ||
| 95358537 | 9535853 | 18 | 20160704 | 0 | ||
| 95358537 | 9535853 | 19 | 20160704 | 0 |